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Dental low speed handpiece
EUDAMEDClass IIa (EU MDR)
Ref Rose 201-M4Model Rose201CA/Rose201CAP/Rose201CAR /Rose201CAR20 /Rose201CAR20B /Rose201CAI/ose201CAI-B/Rose201CAI5/Rose201CAI5-B/Rose201CAI45/Rose201CAI45-B/Rose201SH/Rose201SHR/Rose201SHI/Rose201-M4 /Rose201-B2/Rose202CA/Rose202CAP/Rose202CAP-B/Rose202CAR
Identity
- Trade Name
- Dental low speed handpiece EUDAMEDDental low speed handpiece EUDAMED
- Device Name
- Dental low speed handpiece EUDAMEDDental low speed handpiece EUDAMED
- Model / Reference
- Rose201CA/Rose201CAP/Rose201CAR /Rose201CAR20 /Rose201CAR20B /Rose201CAI/ose201CAI-B/Rose201CAI5/Rose201CAI5-B/Rose201CAI45/Rose201CAI45-B/Rose201SH/Rose201SHR/Rose201SHI/Rose201-M4 /Rose201-B2/Rose202CA/Rose202CAP/Rose202CAP-B/Rose202CAR EUDAMEDRose 201-M4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941617211950 EUDAMED
- Basic UDI-DI
- 69416172LSM4C EUDAMEDB-06941617211950 EUDAMED
- Direct Marketing DI
- 06941617211950 EUDAMED
- EMDN Code
- Z12110102 DENTAL DRILLS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Dental low speed handpiece by Being Foshan Medical Equipment Co., Ltd. — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 69416172LSM4C | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69416172LSM4C | Class IIa | Active |
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Manufacturer
- Manufacturer
- Being Foshan Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000028786
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED bc36733f-6415-42c5-a221-e5274cdf2be0 61 fields · synced Jul 11, 2026
- EUDAMED 819adbf5-0635-4206-8065-11d5353a7c32 61 fields · synced Jun 19, 2026